Z-0499-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 13, 2023
- Initiation Date
- October 19, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: 31004
Reason for Recall
Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, United Kingdom.
Code Information
UDI-DI: 10381780178095 Lot Number/Exp. Date: 6926457 31-May-24